1. Field of the Invention
The invention relates to mountings with self-tightening skirts on an annular collar, in a stationary, removable and airtight manner, with quick installation and removal, specially designed for the biopharmaceutical field. The purpose of such mountings is either the sealing of the end opening formed by the rigid collar or the connection—with communication—to this collar.
2. Description of the Related Art
It is known that in the biopharmaceutical field, the need exists to be able to mount—namely to seal or to connect with communication—in a stationary, removable and airtight manner, pieces such as—or more precisely parts of—receptacles, tubes or ports that are integrated with more or less complex units that can comprise multiple receptacles, multiple tubes, and multiple functional means, combined with one another.
For the sake of simplicity in the presentation, it is suitable to name the two pieces that are thus to be mounted or are thus mounted “first piece” and “second piece.” It is also acknowledged that the object of the mounting, also referred to as an assembly, is either sealing or connection with communication, and that consequently mounting or assembly is defined as either to seal or to connect with communication.
In a traditional way, such receptacles for biopharmaceutical use were made of stainless steel and connected to one or more tubes made of plastic material or stainless steel by means of one or more clamps acting as a flange, comprising two jaws that are connected to one another, for example articulated, and tightening and locking means. The application of such embodiments in the case of receptacles for biopharmaceutical use comprising a pocket made of plastic material has been extended. These pockets are either relatively thin (sometimes called “pillow” pockets or “2D” pockets—D meaning dimensions) or, as the document FR-A-2 781 202 discloses, have two large walls and lateral gussets, so as to be able, once expanded, to assume a three-dimensional shape and to have a volume of 50 liters and more (sometimes called a 3D pocket). Such clamps, also known under the name of “tri-clamp,” are the object of numerous variant embodiments, such as those described in particular in the documents EP-A-1 230 505, U.S. Pat. Nos. 6,708,377, and 7,384,078, whereby this list is not limiting. Such a tri-clamp conventionally comprises a tightening cuff that at each of its two corresponding ends has a bulge, a tightening element working structurally and functionally with the two bulges opposite. The object of the documents EP-A-0 997 155 and EP-A-1 352 851 is the implementation of such clamps or tri-clamps.
In line with the ISO 2852: 1993 Standard, one of the two pieces that is the object of the mounting or assembly, for example the first piece, has an annular part that has an end bulge toward the exterior, in the end edge of which an annular groove is provided that accommodates a sealing bead that is also annular. The other piece, then the second piece, also has an annular part that has an end bulge toward the exterior. The clamp, flange or tri-clamp is designed to be tightened on the two annular parts by keeping them firmly against one another to prevent their inadvertent disassembly and to ensure the sealing.
These embodiments have a certain number of limits and drawbacks. These tri-clamps, which are conventionally for multiple use, are expensive. They are ill-suited to the increasingly common and desired case of single use (per se or for a process overall). Most often, their interior diameter does not exceed about ten centimeters, whereas more and more frequently, the use of biopharmaceutical devices that are larger in size, in particular involving openings of containers, is considered. Their installation often proves difficult, long and hazardous, to the extent where the operator has to hold the tri-clamp and maneuver it (for closing it) and simultaneously hold at least one, and even two, pieces, while keeping them perfectly positioned relative to one another. These drawbacks are unacceptable when, as is more and more often desired, the two pieces have to be able to be assembled quickly and more easily.
Ports that have external holding teeth (sometimes called “hose-barbs”) are also known—for example from document U.S. Pat. No. 5,350,080. These embodiments have a number of limitations and drawbacks. For example, their diameter is limited and does not allow large sizes, and their installation, with force, is problematic.
It is also known that in the biopharmaceutical field, there exists the need for being able to mount or assemble receptacles with sterile chambers for the purpose of a connection with communication in a stationary, rigid, removable and airtight manner. To do this, most often complex systems are used such as those that are described in the documents EP-A-0 800 480 and EP-A-0 865 382. These embodiments are well suited to their use but exclude single use.
One skilled in the art also knows that there exist a number of embodiments of sealing covers, in which a first piece that forms a cover comprises a transverse wall and a peripheral annular wall that forms a skirt, and a second piece for which the cover is designed comprises an annular collar and an end opening (EP-A-1 336 572, EP-A-1 425 227, EP-A-1 666 368, WO 2005/021396, WO 2007/122648). These embodiments are specific to their use and provide answers to individual problems that are not those of the biopharmaceutical field. For example, and in a nonlimiting manner, the object of these embodiments is a mass production designed for everyone, and the mounting or assembly is designed to be able to hold up for a significant period (up to several years) or, conversely, the mounting or assembly is disposable and sealing is not a critical factor. These embodiments therefore cannot be transferred to the biopharmaceutical field for mounting or assembling—in a stationary, rigid, removable and airtight manner—pieces such as receptacles, tubes or ports, or parts thereof, with inherent requirements in the field being considered and with the uses in question.
The document U.S. Pat. No. 2,767,711 that relates to a package for an eye medication is also known from the state of the art. The package comprises a container and a cover equipped with a bead with a general rounded shape in a straight cross-section. The cover further comprises a central part, an annular projection directed upward adjacent to the central part, a curved collar, like the bead, and becoming engaged on it, a terminal lip that by its end comes against the exterior surface of the lateral wall of the container.
However, this document does not provide the fact that the interior surface of the transverse wall comprises a part that is mated with an end edge of the collar that can be applied against it and that can participate in the sealing between the two pieces. Conversely, in the document U.S. Pat. No. 2,767,711, the collar is rounded and therefore lacks an end edge.
In addition, it is no longer provided that the interior surface of the skirt includes a cylindrical part of larger diameter adjacent to the transverse wall, a cylindrical part of smaller diameter separated from the transverse wall, and a tilted, tapered intermediate part, such that, in the active state where the first piece is mounted on the second piece, these parts of the interior surface of the skirt come respectively into contact with elastic holding tightening and sealing on the mating parts of the exterior surface of the collar of the second piece. Conversely, this document provides a curved skirt with a circular shape in cross-section and a terminal lip that comes against the exterior surface of the lateral wall of the container—not by its internal surface but by its terminal field.
Such an embodiment therefore has in particular the drawback that it is not suitable for openings of large diameter.
There therefore exists an unsatisfied need for mounting or assembling—namely sealing or connecting with communication—in a stationary, removable and airtight manner, a first piece and a second piece, such as receptacles, tubes or ports or more precisely parts thereof, used in processes and devices of the biopharmaceutical field with—as inherent requirements—a possibility of single use (per se or for a process overall), a low cost, an installation (i.e., mounting or assembly) and disassembly, an airtight mounting or assembly, a possibility of application in the case of biopharmaceutical devices whose openings involved by the connection can reach about fifty centimeters in diameter, an easy, quick and reliable installation. There is also a need for sets of pieces (a first piece and a second piece) that can be mounted or assembled as indicated and that proceed from a “versatile” idea allowing a great diversity of functions and applications in the biopharmaceutical field. In this field, and in addition to what has already been indicated, it is essential that the materials that are used are such that the components and devices produced from them keep their integrity during sterilization, for example by γ radiation, that the devices that are used meet the approval of the health authorities and are compatible with a white room use. Furthermore, most often, the sets of pieces considered here (first piece and second piece) are designed, within the framework of standard use, to accommodate fluids at atmospheric pressure or close to atmospheric pressure and at positive temperatures between temperatures that are close to 0° C. up to temperatures on the order of 40° C.